A clinical study to assess the effect of riboflavin supplementation with antidepressant treatment in patients with major depressio

Phase 4

Conditions: Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified

Registration Number: CTRI/2022/01/039469

Lead Sponsor: This has been submitted to DST for funding

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Subject of age 18-55 years of either gender.

Patients of MDD diagnosed clinically who have not started /within 15 days of antidepressant treatment

Patients who are prescribed any of the antidepressants (SSRI/SNRI) as monotherapy by the psychiatrist

Patients who can read and understand.

Patients who are willing to participate and give consent.

Exclusion Criteria

Pregnant or seeking pregnancy, lactating women

Patients suffering from any chronic disease like cardiac diseases, respiratory diseases, liver disease, malignancy, peptic ulcer etc, which are known to affect inflammatory or neurodegenerative markers.

Associated neurological diseases other than depression

Progressive brain diseases like alzheimers disease, parkinsons disease, multiple sclerosis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of 3 months riboflavin supplementation with antidepressants (SSRI/SNRI) treatment in patients of Indian origin with major depressive disorder (MDD) on depression severity as assessed by HDRS score.Timepoint: 3 Years

Secondary Outcome Measures

Name	Time	Method
To assess the effect of riboflavin supplementation with antidepressants (SSRI/SNRI) treatment on the oxidative stress (total antioxidant capacity) and safety parameters (renal function test, liver function test and complete blood count).Timepoint: 3 Years;To assess the effect of riboflavin supplementation with antidepressants (SSRI/SNRI) treatment on the quality of life as assessed by HRQoL and social cognition score assessed by SOCRATIS.Timepoint: 3 Years;To compare the expression of the identified proteins/genetic biomarkers levels (BDNF, SLC6A4, HTR1A, HTR1B, IL11) in Indian subjects with MDD (before and after riboflavin intervention) vs. healthy control.Timepoint: 3 Years;To correlate change in treatment response (HDRS score) with the change in identified proteins/genetic biomarkers levels, and oxidative stress.Timepoint: 3 Years